Consistency of the Antidepressant Effect of Intranasal Esketamine in Phase 3 Clinical Trials
Journal of Psychiatric Practice March 1, 2021 DOI: 10.1097/pra.0000000000000531
Summary
This column reviews the development of intranasal esketamine, focusing on the consistency of clinical trial results. It illustrates methodological issues important to the U.S. Food and Drug Administration approval process, including study design, the nature of the comparator, and the prespecified statistical analysis plan. The column discusses what constitutes a positive versus a supportive study, differences between phase 2 and phase 3 studies, and the rationale for including both in development. While especially relevant to intranasal esketamine, it also serves as a general example of drug development and approval.
Study at a glance
| Characteristics | Review Peer reviewed |
|---|---|
| Citations | 3 |
| Key finding | The column illustrates methodological issues in the FDA approval process using intranasal esketamine as an example, emphasizing the importance of study design, comparator choice, and statistical analysis plans. |
Abstract
This column reviews the development of intranasal esketamine with particular emphasis on the consistency of the clinical trial results. In the process, it illustrates methodological issues important in the approval process by an agency such as the United States Food and Drug Administration. Topics covered include the importance of study design, the nature of the comparator, and the prespecified statistical analysis plan. The column also discusses what is considered a positive versus a supportive study and the differences between phase 2 and phase 3 studies and the rationale for including both in the development process. While this information is particularly germane to intranasal esketamine, it also serves as a more general example of the drug development and approval process.